Drive regulatory strategies for Expanded Access Programs across global markets, ensuring compliance and patient access.
Act as a subject matter expert in communications with pharmaceutical clients, health authorities, and cross-functional teams.
Prepare and submit regulatory dossiers while maintaining up-to-date knowledge of global frameworks.
Jobgether uses AI-powered matching to connect candidates with jobs at partner companies. They are a fast-growing global organization with a dynamic scale-up environment and high autonomy.
Drive growth of Regulatory Science and Medical Writing services across pharmaceutical, biotechnology, and life sciences clients.
Lead strategic sales efforts, identify client needs, and partner cross-functionally to deliver tailored solutions supporting regulatory approvals.
Serve as the primary liaison between client and company for all sales-related activities, enhancing visibility and market presence.
Veristat accelerates life-changing therapies to patients worldwide with more than 30 years of expertise. They have a flexible, inclusive culture with 70% remote workforce and 66% women-led teams, having prepared over 105 approved therapies and delivered over 350 rare disease projects.
Provide regulatory advice and ensure compliance with U.S. regulations and ICH GCP guidelines for clinical research sites.
Coordinate IRB submissions, maintain regulatory documentation, and support site start-up and close-out activities.
Collaborate with cross-functional teams and monitor regulatory changes to advise stakeholders.
Care Access is working to make the future of health better for all by bringing world-class research and health services directly to communities that often face barriers to care. With hundreds of research locations, mobile clinics, and clinicians across the globe, the company is dedicated to ensuring every person has the opportunity to understand their health and contribute to medical breakthroughs.
Act as primary clinical point of contact with clients and lead planning, execution, and oversight of clinical studies across Latin America.
Develop country-level recruitment strategies, guide monitoring and quality strategies, and mentor CRAs and partners.
Collaborate with project managers on budgets, vendor management, and ensure compliance with ICH-GCP and regulatory requirements.
Precision Medicine Group is a precision medicine company that provides clinical research and commercialization services. The company is an Equal Opportunity Employer with a focus on expanding clinical operations across Latin America.
Ensure product claims, labeling, and regulatory documentation meet FDA and FTC requirements for dietary supplements.
Work cross-functionally with Brand, Product, Quality, and Marketing teams to translate regulatory frameworks into actionable guidance.
Support GMP compliance, audits, and process improvements to strengthen regulatory operations at scale.
The company is a partner organization managing applications and next steps for a role in consumer health. They are a science-led organization with a growing portfolio of microbiome and nutrition-focused innovations.
Independently prepare IRB documents, maintain regulatory files, and facilitate regulatory oversight of safety reporting for clinical trials.
Serve as the internal project manager for assigned oncology disease groups, providing timely updates and regulatory guidance.
Manage study activation processes and act as liaison between sponsors, investigators, and internal departments.
Emory University is a leading research university that fosters excellence and attracts world-class talent to innovate today and prepare leaders for the future. Winship Cancer Institute is Georgia's only NCI-designated Comprehensive Cancer Center, dedicated to discovering cures for cancer and providing innovative therapies.
Provide study oversight as primary liaison between CRAs, internal staff, site staff, client personnel, and external vendors.
Ensure clinical monitoring activities comply with SOPs, regulations, GCP, KPIs, and study-specific requirements.
Develop and manage clinical plans and guidelines, including the clinical monitoring plan and study timelines.
ProTrials is a women-owned, WBENC-certified Contract Research Organization (CRO) that has been a trusted partner in clinical research since 1996, supporting research behind innovative treatments in pharmaceutical, biotech, and medical device industries. They foster a collaborative community where team members feel valued, supported, and empowered to make a meaningful impact on global health.
Review products for marketability in the EU and USA, ensuring compliance with food regulations.
Collaborate with product management, R&D, marketing, and other teams on regulatory questions.
Monitor regulatory changes and handle official objections from authorities.
The Quality Group is an innovative provider of sports nutrition products, uniting brands ESN and More Nutrition, focusing on healthy, reduced-sugar nutrition and supplements. With over 1,200 employees, they foster a culture of teamwork, responsibility, and innovation.
Conduct and report SIV, RMV, COV onsite monitoring visits and perform CRF review, source document verification, and query resolution.
Manage site communication and be the point of contact for in-house support services and vendors, while communicating with internal project teams on study progress.
Support regulatory teams in preparing documents for study submissions and prepare for and participate in audits and inspections.
The company is a dynamic, global mid-size clinical research organization founded in 1995, bringing together more than 3,000 dedicated individuals. They work on the frontline of medical science, changing lives and bringing new medicines to those who need them.
Manage global clinical trial operations, ensuring adherence to timelines, budget, and quality standards.
Collaborate with cross-functional teams to establish and implement clinical trial protocols and procedures.
Build and manage strong relationships with trial investigators and stakeholders, ensuring regulatory compliance.
ICON is a global healthcare intelligence and clinical research organization that helps bring new medicines and treatments to patients faster. It is a values-driven company with a focus on integrity, collaboration, agility, and inclusion, employing a diverse global workforce.
Lead global regulatory strategy for one or more drug development programs, with emphasis on submissions and health authority interactions.
Plan, manage, and create Clinical Trial Applications, Market Applications, and amendments, ensuring high-quality documents.
Collaborate with cross-functional teams to create and negotiate clinical-regulatory development paths and prepare for health authority meetings.
Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. They are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer.
Oversee Trial Master File (TMF) activities including document review, quality checks, and study-level engagement to ensure regulatory compliance.
Manage a team of Documents Specialists, Quality Review Specialists, and TMF Leads, providing training, performance management, and support.
Collaborate with leadership to drive process improvements and ensure efficient records management across clinical programs.
Precision Medicine Group is a contract research organization providing clinical research services. The company is expanding across Latin America and fosters a collaborative, quality-focused culture.
Define and execute global regulatory strategies across early- and late-stage development for small molecules and combination products.
Lead and oversee interactions with FDA, EMA, and other global regulatory agencies.
Author, review, and submit key regulatory documents, including INDs, CTAs, briefing books, and response packages.
Enveda reinvents drug discovery by harnessing nature's intelligence, identifying new medicines four times faster than the industry standard. The company achieved unicorn status after a $150M Series D in 2025, has an award-winning culture recognized by Newsweek and Forbes, and values creativity, collaboration, and deep respect for each team member.
Serve as a subject matter expert on Canadian consumer protection and payment regulations, providing advisory support to Product, Legal, Risk, and Operations teams.
Oversee Canadian regulatory reporting, lead compliance risk assessments, and evaluate control effectiveness to ensure program alignment.
Maintain and enhance Canada-specific policies, procedures, and control documentation while partnering cross-functionally on remediation efforts.
Affirm is reinventing credit to make it more honest and friendly, offering consumers the flexibility to buy now and pay later without hidden fees or compounding interest. We are a global fintech company with a remote-first culture, dedicated to delivering honest financial products.
Leads writing and preparing clinical and regulatory documents for drug and device development.
Coordinates review, approval, and quality control across functions to ensure compliance and timelines.
Develops knowledge of US and international regulations and participates in process improvements.
AbbVie discovers and delivers innovative medicines and solutions addressing serious health issues in immunology, oncology, neuroscience, and aesthetics. They are a large global biopharmaceutical company committed to having a remarkable impact on people's lives.
Acts as primary site contact and liaison for study management issues, ensuring compliance with ICH-GCP and regulatory requirements.
Manages essential document collection, maintenance, and TMF organization, and coordinates investigator recruitment activities.
Assists with data review, EDC entry, and supports offsite central monitoring and study supply management.
Precision Medicine Group is a clinical research organization providing services to pharmaceutical and biotech companies. The company has a global presence and fosters a collaborative culture focused on precision medicine.
Provide expert regulatory guidance on UK and EU legislation for non-food consumer products, ensuring compliance in specifications and labelling.
Build and maintain strong relationships with clients, suppliers, and internal stakeholders to support compliance.
Monitor regulatory developments and drive continuous improvement of compliance processes and best practices.
SGS is the world's leading testing, inspection and certification company, recognized as a global benchmark for sustainability, quality and integrity. With 100,000 employees and 2,600 offices worldwide, the company is committed to trust, integrity and reliability.
Manage TMF operations activities for multiple complex studies or sponsor portfolios.
Oversee Trial Master File quality control including planning, tracking, and reporting.
Support regulatory inspections and sponsor audits while collaborating with cross-functional teams.
This is a global clinical research environment focused on ensuring accuracy, compliance, and quality of essential trial documentation. The company operates with a collaborative international team and values inclusion, professional growth, and purpose-driven healthcare work.
Manage regulatory relationships by coordinating communications and preparing materials for authorities.
Draft and review regulatory correspondence while supporting governance activities and risk assessments.
Track legislative changes and assist with compliance training, reporting, and cross-functional projects.
Jobgether is an AI-powered job matching platform that connects candidates with hiring companies. They use technology to streamline recruitment and focus on fair, objective candidate evaluation.
Responsible for site activation readiness, including preparation and submission of Clinical Trial Application Forms to Competent Authorities and Ethics Committees.
Manage collection of essential documents, customize informed consent forms, and coordinate translations for study-specific documents.
Maintain communication with key functions (Feasibility, Clinical Operations, Regulatory) and update project trackers and regulatory intelligence tools.
Precision for Medicine is a Clinical Research Organization focused on precision medicine, combining novel clinical trial designs and advanced biomarker solutions, particularly in rare diseases and oncology. The company is growing and seeks dedicated professionals to support its mission, fostering a culture where employees feel appreciated and their ideas valued.